BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERSONA ARTICULAR SURFACE MEDIAL CONGRUENT (MC) LEFT 11 MM HEIGHT

    MDR report key: 19509342 · Received June 11, 2024

    Report

    Report Number
    3007963827-2024-00217
    Event Type
    Malfunction
    Date Received
    June 11, 2024
    Date of Event
    September 26, 2022
    Report Date
    November 27, 2024
    Manufacturer
    ZIMMER ORTHOPAEDIC MFG. LTD.
    Product Code
    MBH
    UDI-DI
    00889024469143
    PMA / PMN Number
    K150090
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: MEDICAL PRODUCT: UNKNOWN FEMORAL COMPONENT: CATALOG#NI, LOT#NI; UNKNOWN TIBIAL TRAY: CATALOG#NI, LOT#NI G2: FOREIGN: GERMANY DILIGENCE IS IN PROCESS TO DETERMINE WHETHER THE PRODUCT IS AVAILABLE FOR EVALUATION. THE INVESTIGATION IS IN PROGRESS. UPON RECEIPT OF ADDITIONAL INFORMATION OR COMPLETION OF THE INVESTIGATION, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: B4; B5; G3; H2; H3; H6; H11. VISUAL AND DIMENSIONAL EVALUATIONS OF THE PRODUCT COULD NOT BE PERFORMED AS NO PRODUCT WAS RETURNED NOR WERE PICTURES PROVIDED. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELATED TO THE REPORTED EVENT WERE FOUND. INVESTIGATION RESULTS CONCLUDED THAT THE REPORTED EVENT WAS DUE TO FAILURE OF THE OPERATOR TO FOLLOW INSTRUCTIONS. PER THE DEVICE INSTRUCTIONS FOR USE, THE SYSTEM COMPONENTS ARE SIZED BY MATCHING THE FEMORAL AND TIBIAL COMPONENT SIZES, STYLES, AND ORIENTATION ON THE PRODUCT LABEL TO THE INFORMATION ON THE ARTICULAR SURFACE COMPONENT LABEL AND/OR PRODUCT COMPATIBILITY CHARTS INCLUDED IN THE PACKAGE INSERT AND SURGICAL TECHNIQUE MANUAL. MISMATCHING MAY RESULT IN POOR SURFACE CONTACT AND COULD PRODUCE PAIN, DECREASE WEAR RESISTANCE, PRODUCE INSTABILITY OF THE IMPLANT, OR OTHERWISE REDUCE THE SERVICE LIFE OF THE IMPLANT. ADDITIONALLY, THE SURGICAL TECHNIQUE IDENTIFIES COMPATIBLE COMBINATIONS. A SUMMARY OF THE INVESTIGATION WAS SENT TO THE COMPLAINANT CONVEYING PROPER SURGICAL TECHNIQUE AND USE OF THE DEVICE. REPORTED EVENT WAS UNABLE TO BE CONFIRMED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL TOTAL KNEE ARTHROPLASTY. APPROXIMATELY ONE (1) YEAR AND SEVEN (7) MONTHS POST-IMPLANTATION, IT WAS REPORTED THAT AN INCORRECTLY SIZED ARTICULAR SURFACE HAD BEEN IMPLANTED. DUE DILIGENCE IS IN PROGRESS FOR THIS EVENT; TO DATE NO ADDITIONAL INFORMATION OR MEDICAL INTERVENTION HAS BEEN REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL TOTAL KNEE ARTHROPLASTY. APPROXIMATELY ONE (1) YEAR AND SEVEN (7) MONTHS POST-IMPLANTATION, IT WAS REPORTED THAT AN INCORRECTLY SIZED ARTICULAR SURFACE HAD BEEN IMPLANTED. NO ABNORMALITIES OR COMPLICATIONS HAVE BEEN REPORTED AND THE PRODUCT REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    824234 PERSONA ARTICULAR SURFACE MEDIAL CONGRUENT (MC) LEFT 11 MM HEIGHT PROSTHESIS, KNEE MBH ZIMMER ORTHOPAEDIC MFG. LTD. 65188978 00889024469143

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Female SEE H11 NARRATIVE.